At a glance
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A Phase III Trial of Carboplatin and Paclitaxel Plus Placebo Versus Carboplatin Paclitaxel Plus Concurrent and Extended Bevacizumab in Chinese Women With Newly Diagnosed, Previously Untreated, Stage III or Stage IV Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
In Brief
A Phase 3 clinical trial evaluating Paclitaxel, Bevacizumab, and 2 other interventions for Ovarian Cancer and 2 related conditions. Completed, enrolled 100 participants across 16 sites.
Detailed Summary
This multicenter, double-blind, 2-arm, randomized study will evaluate the efficacy and safety of bevacizumab plus paclitaxel and caboplatin compared with placebo plus paclitaxel and caboplatin in Chinese participants with newly diagnosed, previously untreated Stage III or Stage IV epithelial ovarian, fallopian tube, or primary peritoneal cancer. Participants whose disease has not progressed after six cycles of paclitaxel and carboplatin with either bevacizumab or placebo will continue treatment with either bevacizumab or placebo until disease progression, unacceptable toxicity, or a maximum of 22 cycles, whichever occurs first.
Study Details
Timeline
Interventions
175 mg/m\^2 IV infusion on Day 1 of each 21-day cycle.
15 mg/kg IV infusion on Day 1 of each 21-day cycle.
Area Under the Curve (AUC) of 6 mg/ml/min on Day 1 of each 21-day cycle.
Placebo matched to bevacizumab IV infusion on Day 1 of each 21-day cycle.